Label: HERBITUAL SKIN PROTECTANT CREAM- dimethicone cream

  • NDC Code(s): 82956-0001-3
  • Packager: Prime Matter Labs West
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 19, 2023

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  • Active Ingredient

    Dimethicone 1%

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent and temporarily protects and helps relieve, chapped or cracked skin.

  • Warnings

    For external use only

    When using this product:

    do not get into eyes.

    Stop use and ask a doctor if:

    • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on:

    • deep or puncture wounds • animal bites • serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply as needed. For best results, apply to damp skin after bathing or showering.

  • Inactive Ingredients:

    Water, Emu Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii Butter, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Euphorbia Cerifera Wax, Curcuma Longa Root Extract, Aconitum Carmichaelli Root Extract, Astragalus Membranaceous Root Extract, Coptis Chinensis Root Extract, Glycyrrhiza Uralensis Root Extract, Phellodendron Chinese Bark Extract, Rheum Plamatum Root Extract, Salvia Miltiorrhiza Root Extract, Sophora Flavescens Root Extract, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol.

  • QUESTIONS

    Distributed by Herbitual LLC.

    2699 1/2 N Beachwood Drive

    Suite 212 Los angeles CA 90068

    www.herbitualskin.com | @herbitualskin

  • Herbitual ATOPIC SKINN DEFENSE Skin Protectant Cream

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    HERBITUAL  SKIN PROTECTANT CREAM
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82956-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE 100 (UNII: RO266O364U) (DIMETHICONE 100 - UNII:RO266O364U) DIMETHICONE 1009.98 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TURMERIC (UNII: 856YO1Z64F)  
    ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ASTRAGALUS MONGHOLICUS ROOT (UNII: 922OP8YUPF)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82956-0001-328 mL in 1 JAR; Type 0: Not a Combination Product01/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/24/2023
    Labeler - Prime Matter Labs West (118568102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Matter Labs West118568102manufacture(82956-0001) , pack(82956-0001) , label(82956-0001)
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